Supernus Pharmaceuticals, Inc. (SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that on May 14, 2020 the Company received a Paragraph IV Notice Letter from Apotex Inc. and Apotex Corp advising Supernus of the submission by Apotex of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for oxcarbazepine extended-release tablets. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights (IPR) relating to Oxtellar XR. Oxtellar XR is currently protected by nine patents listed in the FDA’s Approved Drugs Product List (Orange Book) that expire no earlier than 2027.

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On the call with me today are Supernus' Chief Executive Officer, Jack Khattar; and Chief Financial Officer, Greg, Patrick. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance.

Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs April 28.) * AstraZeneca plc (NYSE: AZN) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) * Black Diamond Therapeutics Inc (NASDAQ: BDTX) * Erytech Pharma SA (NASDAQ: ERYP) * GenMark Diagnostics, Inc (NASDAQ: GNMK) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) * I-Mab ADR (NASDAQ: IMAB) * Imara Inc (NASDAQ: IMRA) * Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA) (reacted to first-quarter results) * Novo Nordisk A/S (NYSE: NVO) * OraSure Technologies, Inc. (NASDAQ: OSUR) * Quest Diagnostics Inc (NYSE: DGX) (announced direct-to-consumer COVID-19 antibody test) * REDHILL BIOPHAR/S ADR (NASDAQ: RDHL) (announced addition of its Talicia, meant to treat H. pylori infection, to Prime Therapeutics NetResults A-Series National Formulary) * Syndax Pharmaceuticals Inc (NASDAQ: SNDX) (presented positive preclinical and initial clinical data for SNDX-5613 in treating genetically defined acute leukemias) * West Pharmaceutical Services Inc. (NYSE: WST) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL) * Zynex Inc. (NASDAQ: ZYXI)None of the Nasdaq- or NYSE-listed biotech/medical device/diagnostics company hit 52-week lows Tuesday.Stocks In Focus Erytech's Lead Drug Granted Fast Track Designation In Second-Line Pancreatic Cancer Erytech Pharma said the FDA has granted Fast Track designation for its lead product candidate eryaspace in treating second-line pancreatic cancer. The candidate is being evaluated in a late-stage study for the indication in 11 countries in Europe and the U.S.Separately, the company provided an update on the pivotal Phase 3 trial of eryaspace in combination with chemotherapy as a second-line therapy for advanced metastatic pancreatic cancer. The company said the third independent safety review has again confirmed the favorable safety profile and that the trial has surpassed 75% of the planned target enrollment.Due to the COVID-19 pandemic, the company said it now sees a limited delay of three to four months in completion of patient enrollment. The company said it now expects an interim superiority analysis around the end of the year and final results in the second half of 2021.The stock was trading 44.15% higher at $11.95 in Wednesday's premarket session. Inovio Announces Positive Interim Data From Midstage Trial Of MERS Coronavirus Vaccine Inovio Pharmaceuticals Inc (NASDAQ: INO) and GeneOne Life Science announced positive interim data from a Phase 1/2a trial of its DNA vaccine INO-4700 for MERS coronavirus. Through week 16, the vaccine recipients showed strong antibody and T cell immune responses after two or three doses with 0.6 mg of INO-4700, the company said.It added that the vaccination was also well-tolerated, with no vaccine-associated severe adverse events."As we have designed our COVID-19 vaccine INO-4800 using the same strategy as INO-4700, including the selection of full length Spike protein as the target and the use of intradermal CELLECTRA device, we are hopeful that the ongoing Phase 1 clinical trial with INO-4800 would generate similar clinical immune responses and safety data as we have just reported for INO-4700," CEO Dr. Joseph Kim said in a statement. Inovio shares were up 5.09% at $14.45 in Wednesday's premarket session.See also: The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight Novartis' Cosentyx Approved In Europe For Spondyloarthritis Novartis AG (NYSE: NVS) said the European Commission has approved Cosentyx for the treatment of adult patients with active non-radiographic axial spondyloarthritis.In premarket trading Wednesday, the stock was down 1.16% at $87.02.Immunomedics Prices Common Stock Offering Immunomedics, Inc. (NASDAQ: IMMU) said it has priced an underwritten public offering of 14.74 million shares of its common stock at $28.50 per share to generate gross proceeds of $420 million. The company expects the offering to close on or about May 1.In premarket trading, Immunomedics shares were trading 5.3% higher at $30.60. Supernus to Buy WorldMed's CNS Portfolio For Up to $530M Supernus Pharmaceuticals Inc (NASDAQ: SUPN) announced a definitive agreement under which it will acquire the CNS portfolio of US WorldMeds, a privately held biopharmaceutical company, for an upfront payment of $300 million, plus cash milestone payments of up to $230 million.View more earnings on IBBThe proposed purchase will help strengthen the neurology portfolio by adding three marketed CNS products and a late-stage pipeline, Supernus said.In premarket trading Wednesday, the stock was gaining 2.67% to $20.01.Merck Gets FDA Nod For Higher Dosage Option For Keytruda In All Adult Indications Merck & Co., Inc. (NYSE: MRK) said the FDA has approved an additional recommended dosage of 400mg every six weeks for its anti-PD-1 therapy Keytruda across all adult indications, including monotherapy and combination therapy.This dosage is in addition to the current dose of 200mg every three weeks.FDA Clears Chimerix For Rolling NDA Submission For Antiviral Drug To Treat Smallpox Chimerix Inc (NASDAQ: CMRX) said it has received clearance from the FDA for a rolling submission of its NDA for brincidofovir as a medical countermeasure for smallpox. The company said it intends to begin the rolling NDA submission in May 2020, with completion targeted for mid-2020.Separately, the company also said it has initiated a Phase 2/3 study of dociparstat sodium in COVID-19 patients with acute lung injury.The stock was advancing 32.45% to $2 in premarket trading Wednesday.Pfizer, BioNTech Dose First Cohort of Participants In Phase 1/2 Coronavirus Vaccine Study Pfizer Inc. (NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) said the first cohort consisting of 12 participants in the latter's Phase 1/2 clinical trial in Germany has been dosed. The companies said they plan to initiate trials for BNT162 in the U.S. upon regulatory approval, which is expected shortly. In premarket trading, Pfizer was rising 1.61% to $38.52 and BioNTech shares were advancing 6.85% to $48.97.reTORbio to Reverse Merge With Adicet resTORbio, Inc. (NASDAQ: TORC) announced a reverse merger with Adicet Bio, Inc., a privately held biopharma, with the focus on developing Adicet's off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications.Earnings AstraZeneca reported better-than-expected first-quarter results and maintained its full-year guidance.Masimo Corporation's (NASDAQ: MASI) first-quarter revenue climbed 16.4% to $269.6 million and non-GAAP net income came in at 97 cents per share, ahead of the 91-cent-per-share consensus estimate.The stock was trading 2.56% higher at $218 in Wednesday's premarket session.DexCom, Inc. (NASDAQ: DXCM) reported first-quarter revenue of $405.1 million, up 44.1%, and its non-GAAP net income per share increased from 5 cents to 44 cents. Analysts had estimated EPS of 14 cents per share.The company said it is suspending its 2020 guidance, citing the uncertainty associated with the COVID-19 pandemic.In premarket trading, the stock gained 7.57% to $337.27.On The Radar Earnings * Alkermes Plc (NASDAQ: ALKS) (before the market open) * Boston Scientific Corporation (NYSE: BSX) (before the market open) * United Therapeutics Corporation (NASDAQ: UTHR) (before the market open) * Laboratory Corp. of America Holdings (NYSE: LH) (before the market open) * Alimera Sciences Inc (NASDAQ: ALIM) (after the close) * AtriCure Inc. (NASDAQ: ATRC) (after the close) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close) * Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close) * SurModics, Inc. (NASDAQ: SRDX) (after the close) * Hologic, Inc. (NASDAQ: HOLX) (after the close)Related Link: A Deep Dive On Coronavirus Vaccine Plays Moderna, Inovio See more from Benzinga * The Daily Biotech Pulse: FDA Approves Sanofi's Meningococcal Vaccine, Pluristem Secures M In Funding For COVID-19 Treatment, Oric Pharma Prices IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Enhances long term growth with potential launch of late-stage product candidate in 2021. ROCKVILLE, Md., April 28, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company entered into a definitive agreement under which Supernus will acquire the CNS portfolio of US WorldMeds, a privately-held biopharmaceutical company.

Supernus Pharmaceuticals, Inc. (SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, and Navitor Pharmaceuticals, Inc., a privately-held company leading the discovery and development of mTORC1-targeted therapeutics, announced today a joint development and option agreement for Navitor’s mTORC1 activator, NV-5138. NV-5138 is a first-in-class, orally active small molecule that directly activates brain mTORC1, the gatekeeper of cellular metabolism and renewal, which is often suppressed in people suffering from depression.

Supernus Pharmaceuticals, Inc. (SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today provides a business update related to the COVID-19 situation. Digital and online strategies currently utilized in-house by the Company’s commercial organization have been implemented nationally by the entire sales and marketing organization to interact with external constituencies. Supply of Trokendi XR® and Oxtellar XR® has not been impacted, and the Company has adequate inventory on hand for both products to continue to be available to patients.

Supernus Pharmaceuticals, Inc. (SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has found the New Drug Application (NDA) for SPN-812 for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD) acceptable for review. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD, SPN-810 for the treatment of impulsive aggression, and SPN-604 for the treatment of bipolar disorder.